Posted in:News Sandoz Enters IPR Battlefield on Humira® Patents By C. Nichole Gifford August 10, 2017 Comments are off Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab). On July 20, 2017,... Read more Tagged with: adalimumab, Humira®, Invalidity, IPR, News, PTAB, Sandoz, USPTO, Validity http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Samsung Bioepis and Merck Launch Renflexis® in the U.S. By C. Nichole Gifford August 9, 2017 Comments are off On July 24, 2017, Samsung Bioepis and Merck & Co., Inc. announced the launch of Renflexis® (infliximab-abda) in the United States. ... Read more Tagged with: Infliximab, Janssen, Merck, News, Remicade®, Renflexis®, Samsung Bioepsis http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News FDA Reauthorization Bill is Enacted–Changes Biosimilar User Fees and Review Model By Aydin Harston August 4, 2017 Comments are off The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by... Read more Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News FDA Grants Tentative Approval for Merck’s Insulin Glargine By C. Nichole Gifford July 25, 2017 Comments are off Merck & Co., Inc. (“Merck”) announced last week that the FDA has granted tentative approval for its insulin glargine injection... Read more Tagged with: Diabetes, Follow-on biologic, Insulin glargine, Lantus®, Legal, LUSDUNA™ Nexvue™, Merck, News, Sanofi http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News FDA Advisory Committee Recommends Approval of CAR-T Cell Therapy and Two New Biosimilars By C. Nichole Gifford July 18, 2017 Comments are off Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public... Read more Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Boehringer Ingelheim Prevails in IPR Against AbbVie’s ’135 Humira Patent By C. Nichole Gifford July 17, 2017 Comments are off Boehringer Ingelheim International GMBH and Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) have prevailed in two... Read more Tagged with: AbbVie, adalimumab, Amgen, Boehinger Ingleheim, Coherus, Humira®, Legal, News, PTAB http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus
Posted in:News Update: BsUFA II Clears the House and Awaits Senate Vote By Aydin Harston and Andrew Storaska July 14, 2017 Comments are off H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee... Read more Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory http://twitter.com/share?text="[TITLE]&url=[PERMALINK]ShareEmail, Linked In, Twitter, Facebook, Google Plus